Sleep Apnea, Central, Ventricular Dysfunction
Conditions
Brief summary
The study evaluate the effect of adaptative servoventilation (ASV) initiation combined with 14 days Zopiclone vs Placebo treatment in patients with central sleep apnea (CSA) syndrome.
Detailed description
ASV remain the optimal treatment for CSA in Heart Failure patients with preserved left ventricular ejection fraction (LVEF). Yet, the adaptation to the ventilation is extremely challenging and the resulting difficulties encountered to sleep induction might be a reason for dropping out. Zopiclone is indicated for the short-term treatment of insomnia where sleep initiation or sleep maintenance are prominent symptoms. In this study, Zopiclone, as sedative and hypnotic agent, is used during the ASV initiation period.
Interventions
DRUGZopiclone
DRUGPlacebo
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged between 18 and 90 years at the initial visit * Central Sleep Apnea with an AHI ≥ 15/h and at least 50% of central events indicating an ASV therapy, as determined by a ventilatory polygraphy (PG) or a polysomnography (PSG) * Cardiac Dysfunction with Left Ventricular Ejection fraction(LVEF)\> 45% determined by a transthoracic echocardiography (TTE), known for more than 12 weeks and stable for at least 4 weeks; * Compliance less than 3 hours after 7 days of the setting up of ASV; * Patient affiliated to a social security scheme or being beneficiary of such scheme; * Patient voluntarily participating in the research, with written informed consent
Exclusion criteria
* Current use of continuous positive airway pressure (cPAP) for treatment of sleep apnea during the last 12 months * Presence of chronic symptomatic heart failure with reduced left ventricular ejection fraction (LVEF ≤ 45%), and a CSA moderate to severe (AHI ≥15 / h) * Presence of severe pulmonary bullous disease * Presence of Pneumothorax or pneumomediastinum * Hypotension, especially if associated with depletion of intravascular volume * Dehydration * Leaking of cerebrospinal fluid, cranial surgery or trauma recently. * Episode of acute respiratory failure or heart failure in the previous month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average use of the Adapative Servo Ventilation device per day assessed by the device data | one month | daily use of the device (hours/day, mean value), amount of hours and number of day the device has been used as assessed by the device data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual Apnea, Hypopnea Index (number/hour) | 12 months | Index assessed by device data |
| Daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS) | 1 month | — |
| Average use of the Adapative Servo Ventilation device per day assessed by the device data | 3 months and 12 months | — |
| Changes in New York Heart Association score | 1 month | — |
| Number of prescription of hypnotics drug | 12 months | — |
| Asthenia assessed by Pichot scale | 1 month | — |
Countries
France
Outcome results
None listed